K031636

Substantially Equivalent

CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX

Applicant: Datascope Corp.
Product code: DSP
Advisory panel: Cardiovascular
Date received: 2003-05-27
Decision date: 2003-08-11
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Mahwh, NJ, US

Adverse events under product code DSP

product code DSP

Death: 317
Injury: 566
Malfunction: 36,831
Other: 4
Total: 37,718

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.